Copyright Litigation: The Real Kryptonite

By William Kronblat

Warner Bros. is set to release the highly anticipated Superman movie starring David Corenswet, Rachel Brosnahan, and Nicholas Hoult in July. Fans are eager to see James Gunn’s interpretation of the iconic character and superhero universe. In 2022, Gunn was appointed co-chair and co-CEO of Warner Bros. new superhero movie studio, DC studios. DC studios replaced DC films after years of executive turmoil. The upcoming Superman film is meant to jumpstart the rebooted DC Comics movie universe under Gunn’s stewardship. 

However, not everyone shares the fans’ enthusiasm. In January of 2025, a copyright lawsuit aimed to block the release of the film in several countries. The lawsuit was filed in United States District Court in the Southern District of New York, as copyright is governed by federal law. But the lawsuit’s intended impact is broader: it seeks to cancel Warner Bros. “Superman” copyrights in 10 countries including Canada, Ireland, and the United Kingdom by asking the court to apply the law of those nations. 

The Lawsuit:

The lawsuit was brought by Mark Warren Peary, the nephew of the late Superman co-creator Joe Schuster and executor of Schuster’s estate. Peary argued that under the copyright laws of those 10 countries, Warner Bros. had lost its right to the Superman copyright. Peary sought compensation from all the works connected to the alleged infringement, including older Warner Bros. titles like Zack Synder’s Justice League, Black Adam, and Shazam. Peary contended that the court had to apply the laws of the countries where the alleged infringement occurred, and that his claims could proceed under the Berne Convention (an international treaty that sets out minimum standards for copyright protection that the U.S. has adopted in part).

Peary’s suit was dismissed this month by U.S. District Court Judge Jesse Furman. Judge Furman held that the court did not have jurisdiction over the dispute and no authority to address the estate’s copyright interest under foreign laws. Peary sought to establish jurisdiction by having the court employ diversity jurisdiction or federal-question jurisdiction, but Judge Furman held that neither applied

Diversity jurisdiction was not present because there were parties from California on both sides of the lawsuit. Diversity jurisdiction cannot occur when even one plaintiff is a citizen of the same state that a defendant is a citizen of. Moreover, federal-question jurisdiction was not present because Peary’s complaint did not raise a federal issue, and his “infringement claims [were] brought explicitly under the laws of foreign countries.” Additionally, given the lack of jurisdiction, Furman did not address the merits of Peary’s claims.

Peary and his attorney, powerhouse copyright lawyer Marc Toberoff, did not publicly respond to comment on Judge Furman’s decision, but they promptly refiled the lawsuit in New York state court. Spokesmen for  Warner Bros. and DC Comics expressed their satisfaction with the decision and reiterated that “DC controls all rights to Superman.”

How did DC acquire ownership of the Superman copyright?

In 1938, Superman creators Jerome Siegel and Joe Schuster sold their rights to the character and story to DC Comics for only $130 ($2,948.50 in today’s market). Superman then appeared under the DC Comics banner in Action Comics No. 1. Since then, the Superman copyright has been a hot button topic for litigation. For instance, in 1947 Siegel and Schuster sued DC to invalidate their ownership rights of Superman. The case ultimately settled with Siegel and Schuster receiving $94,000, which equates to about $1,300,053.72 in today’s economy.

DC still retains control of the Superman copyright despite provisions of U.S copyright law allowing original copyright holders to reclaim domestic rights over their copyright after a certain period of time. This is because Mark Peary’s siblings reached a deal with DC in 1992 that terminated the right in exchange for $25,000 per year.

Warner Bros. owns DC, and as a result has access to the DC intellectual property portfolio which includes copyrights such as Superman. 

What is the  future of the Superman copyright?

Despite Peary’s efforts to refile the suit in state court, it is doubtful that any outcome will impede Warner Bros. and DC’s ability to release Superman this summer. The Superman copyright has been litigated time and time again, but the courts have affirmed Warner Bros. ownership repeatedly. Warner Bros. contractually secured its ability to control the Superman copyright with Schuster’s estate back in 1992. Even with the help of a reputable copyright lawyer, Mark Peary is facing an uphill (maybe even impossible) battle if he wants to get Warner Bros. ownership revoked, in the U.S. or any other country. 

It is noteworthy that the Superman copyright expires in 2034. When the copyright expires it will go into the public domain and everyone will have the ability to use the Superman copyright including Mark Peary. It is also noteworthy that DC has been prepping for the moment their copyrights enter public domain. DC has implemented various strategies to protect their copyrights even when they enter the public domain including creating new versions of the character and maintaining high levels of quality control. Given the implementation of these strategies, and that 2034 is still 9 years away, there is still plenty of time for more litigation of the Superman copyright. 

#WJLTA #Superman #copyright #litigation

Brain Capital: Decoding the High-Stakes Landscape of Neurotechnology Investing

By: Madison Bruner

The neurotechnology (neurotech) industry is experiencing remarkable expansion as venture capital (VC) interest floods the cutting-edge sector. Brain computer interfaces (BCIs) and nerve stimulator technologies frequently transition from research labs to commercial ventures. Investors are left to navigate a vibrant ecosystem of innovation. Investors, entrepreneurs, and lawyers are required to navigate a complex financing landscape, comprising unique development timelines, intellectual property complexities, and a plethora of FDA regulations. While this overview is not exhaustive, the principal issues facing neurotechnology financing will be discussed.

Money, Money, Money: Tracking Investment Momentum

Venture capital investment in neurotech has exploded recently, with total industry funding reaching $2.3 billion in 2024. This is greater than a three-fold increase from 2022 levels, despite broader market volatility. Recently, startups specializing in BCIs are dominating the field, although neuromodulation, neurostimulation, and neuro-AI diagnostics have attracted substantial venture capital interest as well. 

Among the highest-profile startups are:

  1. Neuralink is a company founded by Elon Musk, developing implantable BCIs to restore autonomy to individuals with paralysis. Neuralink has received $680 million over six funding rounds and is reportedly valued at $8 billion
  2. Synchron is a company developing a solution that avoids the need for open brain surgery by using a minimally invasive procedure. Syncrhon raised $145 million in venture capital funding and is reportedly valued at $385 million.
  3. Neurable is a company developing non-invasive BCI headphones and pairing with Neurable AI to enhance focus and reduce burnout. Neurable has raised over $30 million in funding and is valued between $50 million and $100 million.
  4. Paradromics is a company developing a high-data-rate, high-reliability BCI. Paradromics has raised $108 million in funding and is valued between $100M and $500M.
  5. Blackrock Neurotech is a company developing BCIs to provide new hope for people with paralysis & other neurological disorders. Blackrock Neurotech has raised $49.7 million in funding and is currently valued at $350 million. Notably, Tether, a cryptocurrency company, invested $200 million in Blackrock Neurotech in 2024.

NeuroTech Futures’ 2024 Funding Snapshot. https://rb.gy/fic5so

Neurotech’s Real Assets: Intellectual Property and the People Behind It

Multi-Dimensional IP Portfolios

Neurotech startups present unique due diligence challenges as they have multi-dimensional intellectual property (IP) portfolios. Neurotech startups hold an intricate collage of intellectual property spanning disciplines such as neuroscience, engineering, materials science, and AI. As such, neurotech startups will likely touch every type of IP:

  1. Patents: Protects hardware innovations like implantable electrodes, pharmaceuticals, and wearable brain activity monitors. Patents also apply to biological and methodological breakthroughs, including brain mapping techniques and neural stimulation methods.
  2. Trade Secrets: Protects proprietary software algorithms, neural data sets, process know-hows, etc. Trade secret protection is also common for internal processes and other competitive techniques that are difficult to protect under other IP regimes.
  3. Copyright: Applies to research papers, brain databases, and software code used in device interfaces.
  4. Trademarks: Used to protect brand identity, company names, product lines, and logos in a growing and increasingly competitive neurotech market.

Academic Tech Transfer Challenges

IP complexities are compounded when the startup is a spin-out of university research. Founders are typically still affiliated with their research institutions, even after starting a startup. This means investors and their counsel must navigate Bayh-Dole compliance, university licensing agreements, material transfer restrictions, and other complexities. Expert legal counsel is required to maintain and implement proper protections for these dynamic IP portfolios and ensure these protections align with a startup’s business model.

Talent Retention in a Highly Specialized Field

Neurobiologists and neurotech engineers are a valuable but rare form of human capital. Thus, they are heavily recruited by competitors. VCs may demand aggressive IP assignment, non-compete enforcement (despite tumultuous waters), and robust retention incentives.

The FDA Regulatory Maze

Neurotech companies face shifting regulatory landscapes that carry huge investment risks. The evolving approach of the Food and Drug Administration (FDA) to neurotech plays a vital role in investment planning. Firstly, neurotech startups must determine whether their product falls under the FDA’s classification system (Class I, II, or III). All three classes mandate certain regulatory requirements. Most technologies will fall under Class II, which requires FDA clearance through the 510(k) process. More invasive devices, such as implantable BCIs used by Neuralink, fall under Class III, requiring Pre-market Approval (PMA). Clinical trials are required for PMAs, and an Investigational Device Exemption (IDE) can be granted to allow the technology to be tested in a clinical trial in order to collect safety and effectiveness data.

Technology for treating serious conditions (such as paralysis, epilepsy, or severe depression) may qualify for Breakthrough Device Designation. This Designation provides a faster and more interactive pathway through the regulatory system. Other technologies that target conditions affecting fewer than 8,000 individuals annually may fall under the Humanitarian Device Exemption, which is exempt from certain provisions of the Food, Drug, and Cosmetic Act but has certain profit and use restrictions. Where neurotech is paired with AI or other forms of software, the Software as a Medical Device (SaMD) framework is applicable and will require clinical evaluation by the FDA. These overlapping regulatory pathways require that startups have strong in-house compliance teams or hire external counsel.

Once FDA approval is granted, companies have to comply with Good Manufacturing Practices (GMP), which ensure that the device is produced under conditions that assure quality, consistency, and safety.

Deal Structure Innovation: Milestones

Given the highly innovative technology of the neurotech field, deal structures need to be flexible and tailored. These structures accommodate the specific challenges that come along with technological milestones, FDA approvals, and market uncertainty. One of the most common models is milestone-based financing, which links funding to specific, clearly defined milestones such as FDA approval. However, FDA milestones may be a moving target, thereby not offering a concrete baseline. Hybrid models that blend technical, clinical, regulatory, and sales milestones offer additional flexibility.

Privacy and Ethics of Neurotech

Beyond IP and FDA obstacles, there is an emerging debate regarding the ethics of neurotech. Neurotech startups are collecting, processing, and storing extremely sensitive data that is directly sourced from brain activity. This data is more personalized and uniquely intimate as compared to other forms of biometric data, such as fingerprints or facial recognition. Neural data consists of the brain’s electrical signals, thus offering a window into a person’s thoughts, intentions, emotions, and cognitive patterns.

Most existing privacy frameworks, such as the Health Insurance Portability and Accountability Act (HIPAA) and the EU’s General Data Protection Regulation (2018) (GDPR), do not explicitly address the protection of neural data. Therefore, there is an urgent need for new laws or amendments that recognize cognitive data as a special class meriting heightened protection. Some forward-thinking jurisdictions, such as California and Colorado, are already paving the way.

For investors and entrepreneurs alike, ethical frameworks are not only a commodity but a necessary prerequisite to risk mitigation. VC firms are now evaluating startups not just on the strength of their ethical governance as well as technological feasibility or commercial potential.

Conclusion: Implications for Startups and Investors

Neurotech is one of the most promising but legally intricate frontiers in venture capital today. Investors and founders alike must navigate complex challenges spanning regulatory compliance, intellectual property protection, team building, capital allocation, and data governance. With sophisticated legal counsel, investors, and entrepreneurs can navigate the complex neurotech landscape more effectively and capitalize on this new frontier. In a world where data is the new oil, investors are eager to find the next unicorn that leverages cutting-edge technology and neural data, effectively turning our wildest science fiction dreams into reality.

#Neurotech #VentureCapital #FDARegulations

From Bars to Briefs: Drake vs. Kendrick Meets the Courts

By: Joseph Valcazar

The rap industry is no stranger to a diss track. Whether it was the rap battles of Tupac v. Notorious B.I.G., Nas v. Jay-Z, N.W.A. v. Ice Cube, or Eminem v. Ja Rule, music has been and continues to be a medium for artists to express their opinion of others in the industry. Typically, this bad blood stays within the confines of lyricism; but on occasion the legal system gets involved. An ongoing legal battle between one of the largest artists and largest record labels is the latest adventure of a rap battle turning legal. 

A diss track is a song targeted at a specific individual or group (usually another artist) that includes lyrics meant to publicly attack or disrespect them. In 2024, Kendrick Lamar and Drake, two of the largest rap artists in the world, traded diss tracks, bringing in millions of views every day, and generating months of online discourse. While the musical back and forth ended in May 2024, the artists’ feud reached a new boiling point in January 2025 when Drake filed a civil lawsuit in federal court against Universal Music Group (UMG) — the record label that represents both Kendrick and Drake. The lawsuit raises interesting questions on First Amendment free speech and defamation stemming from song lyrics.

The Timeline

While the story of Kendrick and Drake’s contentious relationship can be traced back over a decade, this saga began with the release of “First Person Shooter,” a collaboration between Drake and J. Cole containing a verse that crowned Drake, J. Cole, and Kendrick the big three of rap. This sparked a response from Kendrick in a featured verse on Future’s album, where he dismissed the big three and declared “it’s just big me.” 

This began a multi-month back and forth, consisting of eight tracks, that escalated into personal callouts between the two artists. On May 4, 2024, Kendrick would release his final track of the back and forth, and the song at issue in the lawsuit, “Not Like Us.” The track contains lyrics insinuating Drake has had inappropriate relationships with minors, which lay at the center of his claim against UMG. This song would transcend the rap battle and enter the mainstream; topping the Billboard Hot 100, amassing over one billion streams, and earning Kendrick Grammys for “Record Of The Year,” “Best Rap Performance,” “Best Rap Song,” and “Best Music Video.” Eight months after the release of Not Like Us, Drake would file his lawsuit against UMG.

The Lawsuit

Drake is clear in his complaint that this is not a lawsuit against Kendrick Lamar. Rather, the lawsuit has been filed against UMG, one of the largest record labels in the world. The lawsuit filed by Drake — whose legal name is Aubrey Graham — claims that the label has defamed him by promoting the song “Not Like Us”, which, as mentioned, insinuates Drake had inappropriate relationships. It is further alleged that UMG has artificially inflated streams through botting to boost the perceived success of the song. Drake believes the combination promotion and inflated popularity has directly led to threats and harassment, all of which have led to Drake suffering reputational harm, while the record label profited from the success of Kendrick’s song. Drake filed this lawsuit one month before Kendrick Lamar would perform “Not Like Us” to a live audience of over 130 million at the Super Bowl halftime show. In response, an amended complaint to claim that Kendrick’s performance and Grammy success further damaged his reputation. 

The Defamation Claim

Does Drake’s claim hold any weight? The answer isn’t crystal clear. 

To succeed on a typical defamation claim a plaintiff must establish four elements

  1. A false statement is made that is presented to be fact; 
  2. The statement is published or communicated to a third party;
  3. Defendant’s fault in releasing the statement amounts to at least negligence; and 
  4. Some reputational harm occurred to the person targeted by the statements. 

Here, Drake will have to establish an additional element. In the Supreme Court’s landmark New York Times v. Sullivan opinion, the Court established a legal doctrine that requires a plaintiff to prove actual malice when they are a public figure (someone who has achieved prominence and/or influence in society’s affairs). Establishing actual malice requires a heightened “clear and convincing” evidentiary standard; a middle ground between the civil “preponderance” standard and criminal “beyond a reasonable doubt” standard. 

Drake is undeniably a public figure. To show actual malice he must prove that UMG promoted Not Like Us with “reckless disregard of whether [the statement] was false or not.” Given this heightened standard, proving a defamation claim as a public figure is substantially more difficult than for an average citizen.  

UMG filed a motion to dismiss which raised the “rhetorical hyperbole” defense. Rhetorical hyperbole refers to exaggerated statements that a reasonable person would not take literally. This is an interesting legal doctrine in the context of rap battles. After all, the objective is to one-up each other’s lyrical call-outs until one artist is declared the “winner” through public opinion. It’s not as if “Not Like Us” came out of nowhere. Drake was an active participant in this back-and-forth. His own lyrics made claims that Kendrick was unfaithful and physically abusive to his partner. 

This would not be the first time UMG has raised a successful rhetorical hyperbole defense. In 2005, record producer Armen Boladian sued UMG about a verse performed by George Clinton containing  lyrics that painted Boladian as an abuser. The lyrics referred to him as “a disgrace to the species.” The Sixth Circuit Court of Appeals held that Boladian “failed to meet their burden of showing an actual, objectively verifiable defamatory statement”. The court noted the colorful lyrics to be the “kind of puerile taunt that, for better or worse, is typical of rap music.” Do Kendrick’s lyrics fall within this typicality of rap music? This will be a central question as litigation continues.

Conclusion

Is this a case of “be careful what you wish for?” Or has Kendrick overstepped the traditional protections afforded to musical works by courts and into defamation territory? Either way the legal battle for Drake appears to be an uphill one. Concerns about the potential chilling effect that artists may face if Drake were to win have also been raised. If litigation becomes the primary response to any perceived notion of defamation, a natural consequence of this would be the stifling of artistic expression as artists attempt to avoid liability that they previously felt insulated from. Whatever the end result, what started as a rap battle for the ages will be discussed and read about by law students in their entertainment law course for decades to come.

#WJLTA #DrakevsKendrick #Defamation 

Hitting Refresh: How Drug Companies Use Patents to Extend Their Monopoly Power

By: Alexander Okun

  On April 17, 2025, the non-profit Initiative for Medicines, Access, and Knowledge (“I-MAK”) published a report detailing the tactics that two pharmaceutical companies use to maintain their monopolies for their popular diabetes and obesity drugs. The two drugs are Semaglutide (marketed by Novo Nordisk as Ozempic, Rybelsus, and Wegovy) and Tirzepatide (marketed by Eli Lilly as Mounjaro and Zepbound). According to I-MAK, Novo Nordisk and Eli Lilly will effectively extend their patent-based monopolies on these drugs for up to a decade. The tactic of  “patent thickets” is not new to the pharmaceutical industry, but its potential economic impact as applied to these products (known collectively as “GLP-1” drugs) could be on a scale previously unseen. Given the adverse impact this could have on US patients, the need for legal reform is greater than ever.

“Patent Thickets” and Their Uses

A US pharmaceutical patent provides 20 years of protection, after which other manufacturers can produce generic versions of the drug. However, drug companies often file an array of patents for aspects beyond the drug’s core ingredients (called a “patent thicket”) like the method of administration. Subsequent changes to the product may also get patented (known as “secondary” or “follow-on” patents) but can be as minor as adding a dose counter to the injection device. Follow-on patents can also protect purportedly “new” applications of a drug without making any changes, even though those “novel” uses were  disclosed in the initial patent. For example, Eli Lilly’s Mounjaro is approved to treat diabetes while Zepbound is approved for weight loss even though Tirzepatide’s original patent disclosed both uses.

This practice is neither novel nor unique to the GLP-1 market: a 2018 report by I-MAK found that in 2017, the top 12 grossing medications in the US had an average of 71 active patents each, extending each drug’s protection for an average of 18 years. However, the profitability of those extensions is miniscule relative to the potential with GLP-1 drugs. Whereas the top-selling drug in I-MAK’s 2018 report, Humira, produced roughly $200 billion in revenue in its first 20 years, the GLP-1 market is projected to reach $150 billion in annual revenue by 2030. Novo Nordisk has already extended its patents for Ozempic and Wegovy by five years (expiring in 2031), which I-MAK says will deliver $166 billion in additional profits. As of now, patent thickets have effectively extended the protections for Semaglutide by 10 years (expiring in 2042) and Tirzepatide by five years (expiring in 2041). 

Potential for Reform

High drug prices are a perennial issue in US politics, and two proposals appear most promising in preventing further abuses of the patent system. The first approach is to limit the number of patents that can be cited in an infringement lawsuit. This would reduce the deterrent value of patent thickets by limiting the complexity of infringement actions (therefore defendants’ costs) and reducing plaintiffs’ likelihood of succeeding. The Affordable Prescriptions For Americans Act would implement this strategy, and on April 10 it was placed on the Senate’s legislative calendar. However, some analysts say the bill’s exemptions and waivers could make it largely ineffective.

A second option is to crack down on petitions that delay the approval of generic drug versions by using the filer’s patent thickets. The “Stop STALLING Act,” would enable the Federal Trade Commission (“FTC”) to sue filers if it deems a petition “objectively baseless” and intended to “interfere with the business of a competitor.”  However, the requirement of government intervention creates greater administrative costs and potential inconsistencies in enforcement. On April 10 the Stop STALLING Act was also placed on the Senate’s legislative calendar. While both bills have potential and bipartisan sponsorship, they have failed to garner sufficient support in their past iterations. Last year the Affordable Prescriptions for Patients Act passed the Senate unanimously but was never scheduled for a vote in the House of Representatives; the Stop STALLING Act never received a vote in the Senate whatsoever. Hopefully, the resounding success of GLP-1 drugs despite their exorbitant pricing will trigger public interest broad enough to provoke Congressional action.

Puff or Pass? Supreme Court Sides With FDA in Ruling on Flavored Vapes

By: Olivia Bravo

On April 2, 2025, the Supreme Court issued a ruling that reaffirmed the Food and Drug Administration’s authority to regulate flavored e-cigarettes, denying a challenge brought by vape manufacturers. This decision is a significant landmark for administrative law and public health advocates. Why was this decision so controversial? And what does it tell us about how courts balance corporate interests with public well-being?

Background

The Food and Drug Administration (FDA) is the administrative agency responsible for overseeing the introduction of new food and drug products into interstate commerce. Before approving new products to be marketed to the general public, the FDA requires manufacturers to submit premarket applications with  “robust” scientific data for review, demonstrating that their products are “appropriate for the protection of public health.” The FDA has the specific authority to regulate the manufacture, distribution, and marketing of tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). In 2016, the Tobacco Control Act was amended under the Obama Administration to include e-cigarettes as products subject to agency review. 

Like many federal agencies, the FDA must act in accordance with the Administrative Procedure Act of 1946 (APA), which defines the limits of its regulatory authority and outlines the procedures it must follow when creating or enforcing rules. The APA, mandates transparency, consistency, and fairness in agency actions. That legal framework became central to the industry’s challenge. (See APA, 5 U.S.C. § 553). 

The Legal Challenge: FDA v. Wages and White Lion Investments, LLC

In the precursor Fifth Circuit case FDA v. Wages and White Lion Investments, LLC, plaintiffs White Lion and other manufacturers of e-cigarettes submitted to the FDA applications to market their flavored tobacco products – but were rejected for lacking long-term studies demonstrating health benefits and marketing plans that met regulatory standards. 

The companies pushed back hard, arguing that the FDA had applied inconsistent and opaque standards, effectively moving the goalposts without notice. They claimed that flavored vapes were unfairly singled out and that the FDA’s review process was arbitrary, violating the APA. They contended that this created an uneven playing field, treating flavored e-cigarettes more harshly than other tobacco products and leaving applicants to guess at the “robust standards” they needed to meet. The Fifth Circuit ultimately agreed, holding that the FDA acted outside the scope of its authority. The case was then appealed to the Supreme Court, which granted cert.

FDA Denial and Industry Pushback

What is the crux of the matter? Why did the FDA  deny the companies’ applications to sell their e-cigarettes? 

E-cigarettes and vapes are only two of the many electronic delivery system (ENDS) products that use an “e-liquid” nicotine derived from tobacco (as well as flavorings) as an aerosol that is inhaled. In this case, White Lion’s rejected products included flavors like Killer Kustard Blueberry, Rainbow Road, and Pineapple Express, sold in brightly colored packaging resembling candy or cartoons. The FDA argued that this targeted marketing posed a significant risk to youth. In the last decade, the United States has seen an explosive rise in adolescents’ vaping and the renormalization of smoking, especially among high schoolers. In 2024, 1.63 million middle and high school students used e-cigarettes. Recent statistics show that flavor is one of the most important factors adolescents consider when trying e-cigarettes for the first time. 

The vaping industry continues to frame flavored e-cigarettes as a public health innovation—a tool for adult users seeking an alternative to traditional cigarettes. Companies like Triton and Vapetasia claim their flavored vapes provide a public good by helping adult smokers quit cigarettes, with flavors making it more likely that adult smokers will transition away from combustible tobacco. However, the FDA found that e-cigarettes pose a “known and substantial” risk to youth, and concluded that the risks of bringing a new product to market outweighed any potential benefit. 

Supreme Court Review: Reversing the Fifth Circuit

Earlier this month, in the unanimous Supreme Court decision, Justice Alito agreed with the FDA that the flavored e-cigarettes and vapes proved a danger to the health of young people, writing “the kaleidoscope of flavor options adds to the allure of e-cigarettes and has thus contributed to the booming demand for such products among young Americans.” The Court found that the FDA’s actions did not violate the APA and were consistent with its regulatory responsibilities

The Supreme Court and the Fifth Circuit’s decisions differed based on their standards of procedural adherence. While the Fifth Circuit applied a stringent standard, arguing that the FDA acted arbitrarily and capriciously by shifting its standards, the Supreme Court deferred to the FDA’s expertise when no formal policy changes were in place, arguing that their decisions were not outside the scope of their authority. This divergence highlights the broader tension between judicial oversight of agency action and deference to agency expertise in complex regulatory matters, especially those that will have long-term effects on public health.

Conclusion

The Supreme Court’s decision affirms the FDA’s authority to prioritize public health and interstate commerce. In terms of implications for the vaping industry, it is clear the court has drawn the line in the sand between commercial interest and public health priorities, and set a standard for the prioritization of the youth impact over the harm to adult cigarette smokers. While this Court might have previously made different decisions concerning federal agency regulation, it is clear that the targeted health risk to youth was enough of a concern to find in favor of the FDA, whereas in another case, the Court might have gone the other direction.  

Overall, the controversy in this case was a big wake-up call for the FDA and all regulatory agencies that set guidelines for growing and advancing industries. While it might have been easier to set standards for cigarettes when the harmful effects of lung cancer were widely known, the technological and marketing advances of e-cigarettes and other alternative tobacco products have made it difficult for the FDA to keep up with both the pace of innovation and the health implications. Why leave the question of clear regulatory standards and guidelines up for interpretation? Change requirements to keep pace with the advancing world and give notice of those changes in line with transparency.  

#E-cigarettes #FDA #Regulatoryauthority #WJLTA